Many medical procedures involve accessing blood vessels in and around the heart, often by making an incision, puncture or other aperture in the femoral artery in the area of the groin or upper thigh and inserting a medical device into and up through the femoral artery. Access may also be gained via other major arteries in the body. For the purposes of this application, a puncture as discussed should be considered to include an incision, slit or circular opening that passes through the wall of a blood vessel. The terms blood vessel wall aperture, wound aperture, puncture and incision are not to be considered to be limited to any particular shape of opening. A blood vessel wall aperture, puncture or incision includes any opening made in a blood vessel wall or the wall of another bodily organ. This may include but is not limited to surgical incisions, punctures made by needles and openings created with a trephine.
Once the medical procedure is completed, an aperture is left in the wall of the artery or vein that has been accessed. These apertures tend to bleed, particularly in the case of arterial punctures because of the higher arterial blood pressure as compared to the venous blood pressure. To stop bleeding in these situations, it is common for medical personnel to hold pressure on the punctured arterial or venous wall for a substantial period of time after the medical instruments are withdrawn. It is commonly required to hold pressure on the puncture wound for 15 to 30 minutes to stop bleeding. If the patient has been treated with large amounts of anti-coagulant medication, the time required for applying pressure to cause clotting at the puncture site may be substantially extended.
After bleeding has stopped an elastic pressure bandage is typically applied over the site of the puncture to exert pressure on the site in an attempt to prevent the blood clot from being dislodged by blood flow within the blood vessel. With this scenario, it is often necessary for the pressure bandage to remain in place from 8 to 24 hours. Often, the use of a pressure bandage prevents ambulation of the patient and requires that the patient remain resting in bed.
Various attempts have been made to address this problem by suturing closed the aperture or by blocking or sealing the aperture with structures that are either inserted into the blood vessel puncture or applied just external to the blood vessel at the aperture site.
Prior art efforts to address this problem have included suture devices, which do not provide a complete closure or seal of the puncture wound such as the Perclose device. Also used have been staple based devices such as the Starclose device, which attempts to pinch the vessel puncture closed. Other devices have utilized balloons or toggle bolt like structures in an effort to close the puncture wound left behind after intravascular procedures.
Unfortunately, none of these prior art devices has been as successful as would be desired. As such, there is still room for improvement in such vascular closure techniques.